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October 1998

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Fri, 2 Oct 1998 00:03:38 -0400
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Tina,
At one point we were testing for anaerobes annually in the aseptic fill
facility.  I believe we were using a Culturette swab with a transport medium
designed for anaerobes.

At 10:24 PM 9/24/98 -0400, Tony & Roz Cundell wrote:
>At 11:22 AM 9/24/98 -0700, you wrote:
>>Hello everyone;
>>We were requested to check for anaerobes in our cleanrooms.
>>What is the best way to pick up anaerobes from surfaces?
>>What is the best way to identify them?
>>Thanks in advance for your responses.
>>Tina Khavaran
>>
>Tina,
>
>There were a number of studies in the literature that supported the view
>that routine anaerobic monitoring is not necessary.  This view was repeated
>by Terry Munson when he was at the FDA in a review article.
>
>Furthermore, the USP General Information chapter does not recommend routine
>anaerobic monitoring.  I would encourage you to get your management to
>decline this request unless you have had sterility test failures with
>anaerobes isolated.
>
>Tony Cundell
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>
>
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>
Betty Darner
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